Active substance
Ketoprofen
- SFDA 13
- US FDA 16
- EMA 1
- Health Canada 3
- US price lines 1
- NHS prices 1
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FASTUM 2.5% GEL | 2.5 % | Gel · Topical | 1 Tube | SAR 10.30 | Generic · Prescription | A MENARINI INDUSTRIE FARMACEUTICHE S.R.L | Valid |
| Fenajet | 100 mg | Solution for injection · Intramuscular use | 6 Ampoule | SAR 34.15 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| KETOFAN 25MG TAB | 25 mg | Tablet · Oral use | 20 Blister | SAR 8.20 | Generic · Prescription | ALAMRIAH FOR PHARMACEUTICALS INDUSTRIES | Valid |
| Deeprub | 2.5 % | Gel · Topical | 1 Tube | SAR 20.60 | Generic · Prescription | JERASH PHARMACEUTICALS LIMITED COMPANY | Suspended · Not Marketed |
| KETOFAN 25MG TAB | 25 mg | Tablet · Oral use | 10 Blister | SAR 3.90 | Generic · Prescription | ALAMRIAH FOR PHARMACEUTICALS INDUSTRIES | Withdrawn by MAH · Not Marketed |
| ORUVAIL S-R CAPS 100 MG | 100 mg | Prolonged-release capsule, hard · Oral use | 28 Blister | SAR 33.65 | NCE · Prescription | sanofi-aventis | Invalid · Not Marketed |
| PROFENID 100MG I.M VIAL+SOLV. | 100 mg | Powder and solvent for solution for injection · Intramuscular use | 6 Vial | SAR 33.30 | NCE · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
| PROFENID 100MG SUPP. | 100 mg | Suppository · Rectal use | 12 Blister | SAR 14.85 | NCE · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
| PROFENID 100MG TAB | 100 mg | Film-coated tablet · Oral use | 30 Blister | SAR 22.70 | Generic · Prescription | sanofi-aventis FRANCE | Withdrawn by MAH · Not Marketed |
| PROFENID 100MG TAB | 100 mg | Film-coated tablet · Oral use | 30 Blister | SAR 22.70 | Generic · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
| PROFENID 2.5% GEL | 2.5 % | Gel · Topical | 1 Tube | SAR 11.20 | NCE · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
| PROFENID L.P 200MG TAB | 200 mg | Prolonged-release tablet · Oral use | 14 Blister | SAR 34.90 | Generic · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
| PROFENID L.P 200MG TAB | 200 mg | Prolonged-release tablet · Oral use | 14 Blister | SAR 34.90 | Generic · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
LOW BACK PAIN; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS; POSTOPERATIVE PAIN
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| KETOPROFEN | 50MG | capsule · oral | TEVA | Prescription | 22 Dec 1992 |
| KETOPROFEN | 25MG; 50MG; 75MG | capsule · oral | MISEMER | Prescription | 29 Jan 1993 |
| KETOPROFEN | 200MG | capsule, extended release · oral | MYLAN | Prescription | 20 Feb 2002 |
| ORUDIS | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | WYETH AYERST | Discontinued | 9 Jan 1986 |
| KETOPROFEN | 25MG | capsule · oral | TEVA | Discontinued | 22 Dec 1992 |
| KETOPROFEN | 75MG | capsule · oral | TEVA | Discontinued | 22 Dec 1992 |
| ORUVAIL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule, extended release · oral | WYETH PHARMS INC | Discontinued | 24 Sep 1993 |
| ORUDIS KT | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | WYETH CONS | Discontinued | 6 Oct 1995 |
| ACTRON | 12.5MG | tablet · oral | BAYER | Discontinued | 6 Oct 1995 |
| KETOPROFEN | 50MG; 75MG | capsule · oral | RISING | Discontinued | 29 Dec 1995 |
| KETOPROFEN | 50MG; 75MG | capsule · oral | RISING | Discontinued | 31 Dec 1996 |
| KETOPROFEN | 200MG | capsule, extended release · oral | ALKERMES GAINESVILLE | Discontinued | 10 Dec 1997 |
| KETOPROFEN | 200MG; 100MG; 150MG | capsule, extended release · oral | ACTAVIS LABS FL INC | Discontinued | 24 Mar 1999 |
| KETOPROFEN | 12.5MG | tablet · oral | PERRIGO | Discontinued | 7 Feb 2002 |
| KETOPROFEN | 150MG; 100MG | capsule, extended release · oral | MYLAN | Discontinued | 20 Feb 2002 |
| NEXCEDE | 12.5MG | film · oral | NOVARTIS | Discontinued | 25 Nov 2009 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| KETOPROFEN SR | 02172577 | 200 MG | TABLET (EXTENDED-RELEASE) · ORAL | AA PHARMA INC |
| KETOPROFEN-E | 00790435 | 50 MG | TABLET (ENTERIC-COATED) · ORAL | AA PHARMA INC |
| KETOPROFEN-E | 00842664 | 100 MG | TABLET (ENTERIC-COATED) · ORAL | AA PHARMA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | KETOPROFEN ER 200 MG CAPSULE | $6.46184 | per EA | 18 Mar 2026 |
| NHS Drug Tariff | Ketoprofen 2.5% gel | £5.51 | 50 gram | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 17 Apr 2020 PRAC signal: Serious exacerbation of infections
Action for MAH: update of the product information: Yes - EMA PRAC 31 Oct 2019 PRAC signal: Serious exacerbation of infections
Action for MAH: update of the product information: No - EMA PRAC 16 May 2019 PRAC signal: Serious exacerbation of infections
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.